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Informing the design of a clinical trial into umbilical hernia repair

Assessment of Surgeon Treatment Equipoise & Randomisation Opinion to Inform trial Design (ASTEROID)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN56702141
Enrollment
100
Registered
2025-06-30
Start date
2025-05-01
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery Surgery

Interventions

Potential participants will attend hospital with an umbilical hernia which is either stuck (non-reducible), is causing bowel blockage (obstructed), or has lost blood supply to its contents (strangulat

Sponsors

University of Birmingham
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adult patients undergoing emergency open repair of a strangulated, incarcerated, or obstructed umbilical hernia

Exclusion criteria

Exclusion criteria: 1. Patients who are pregnant will not be eligible as they have altered abdominal wall biomechanics 2. Patients with cirrhosis will not be eligible due to different disease processes driving outcomes

Design outcomes

Primary

MeasureTime frame
Time to recruit patients, measured as the number of patients consented into ASTEROID per centre per month

Secondary

MeasureTime frame
1. The proportion of patients retained in the study at 30 days post-surgery will be derived from the number of fully completed PROMs at the 30-day timepoint / the number of patients consented at baseline 2. The proportion of surgeons willing to randomise the patient for repair type and post-surgical antibiotics will be assessed as those willing to accept the theoretical randomised allocations over those who would not, measured at baseline 3. Reoperation on hernia within 30 days, collected as a specific variable on the 30-day follow-up form 4. Surgical site infection within 30 days (defined using CDC criteria) 5. Surgical site occurrence within 30 days (defined as surgical site infection OR seroma [clinical/radiological] OR wound dehiscence)

Countries

England, United Kingdom

Contacts

Public ContactMichala Pettitt
bhamred@contacts.bham.ac.uk-

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: May 1, 2026